Infuse® Personal Injury Actions Returned to State Court

A federal court in Kentucky has refused to hear two product liability actions against Medtronic, Inc. (Medtronic), involving its Infuse® bone graft device and remanded them to state court, where the injured plaintiffs originally sued. In Dillon v Medtronic, Inc., the court rejected Medtronic’s argument that the cases depended on federal law because the Food and Drug Administration (FDA) regulates medical devices. In Worrix v Medtronic, Inc., the court ruled that jurisdiction based on diversity of citizenship was not available.

The Infuse Device

Medtronic’s device stimulates bone growth and is used in place of autologous bone grafts from other parts of the patient’s body. It is comprised of two parts, recombinant human Bone Morphogenetic Protein (rhBMP) and a metal cage, which serves as a carrier to release the protein.

The FDA first approved the device in 2002 for use in treatment of degenerative disease in the lumbar spine. The agency later granted approval for use in treatment of recent, open fractures of the tibia and in certain dental and maxillofacial procedures. However, off-label use became popular among orthopedic surgeons, particularly in cervical spine fusion.

Reported Complications

In 2008, the FDA issued a warning letter discouraging use of the device in the cervical spine because of reports of life-threatening complications. Specifically, the FDA had received reports that swelling of the neck and throat had obstructed patients’ airways and/or neurological structures of the neck. Patients had experienced difficulty breathing or speaking, and there were reports of severe dysphagia, or difficulty swallowing. The letter suggested that clinicians use Infuse only in accordance with the FDA approval or that they enroll as investigators in clinical trials.

Alleged Irregularities

About 75 percent of the complications reported to the FDA involved off-label use of Infuse. The Senate Finance Committee investigated allegations that Medtronic improperly influenced investigators’ reports of their trials of Infuse and found that company employees edited and wrote portions of the articles and that it had paid millions of dollars to the authors of studies. In the spring of 2012, the company also paid $85 million to settle a shareholders’ class action alleging that it marketed Infuse for off-label use and failed to disclose that the vast majority of Infuse sales were for off-label procedures.

The Recent Rulings

Both the Dillon and Worrix plaintiffs sued under state tort law; 21 USC sec. 337(a) bars private civil actions to enforce FDA requirements. They contended that Medtronic continued to market the device for off-label use even though it knew that Infuse was not safe for those uses and that it is unlawful to market devices for off-label uses. Medtronic argued that the plaintiffs’ tort claims were preempted by federal law because 21 USC sec. 360k(a)(1), bars any state law claims to the extent that they are based on requirements that were different from, or in addition to, federal law.

The court ruled that the plaintiffs’ claims did not arise under federal law. 28 USC sec. 1331 provides for federal jurisdiction when plaintiffs’ claims arise under federal law. Medtronic’s’ preemption defense depended on federal law, but the existence of a federal defense does not confer jurisdiction. Although state tort law could not be enforced to the extent that it was more stringent than federal law, the state law obligations were independent of federal law. Therefore, the court could not exercise jurisdiction under the “federal question” statute.

Diversity of Citizenship

In the Worrix litigation, the injured patient sued medical practitioners and the hospital where the surgery was performed in addition to Medtronic. Medtronic claimed an alternative basis for federal jurisdiction based on diversity of citizenship, i.e., the plaintiff’s residence in Kentucky and Medtronic’s state of incorporation and principal place of business elsewhere. However, 28 USC sec. 1332 provides that federal jurisdiction may be based on diversity of citizenship only if none of the defendants is a resident of the same state as the plaintiff. Both the hospital and the practitioners were residents of Kentucky, however. The federal court could hear the case only if there was no basis for her lawsuit against any of the Kentucky defendants. Because Medtronic could not establish that Worrix’s medical malpractice claims were baseless, the court remanded the cases to state court.